Home use of a light therapy device for managing severe gum disease
Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
This study is testing a home light therapy device to see if it can help people with severe gum disease by reducing plaque and improving gum health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Koite Health Oy Industry-sponsored |
| Locations | 1 site (Kaunas) |
| Trial ID | NCT05698823 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Lumoral method, a home-use device that employs antibacterial photodynamic therapy (aPDT) to manage chronic stage III-IV periodontitis. Participants will use a specially designed mouth rinse that adheres to dental plaque, which is then activated by a light applicator to enhance plaque control and potentially improve periodontal tissue health. The study aims to assess both the reduction of plaque and any anti-inflammatory effects resulting from this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III-IV periodontitis and at least 20 teeth.
Not a fit: Patients with grade A or C periodontitis, systemic diseases affecting healing, or those who have recently undergone periodontal treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve oral health and quality of life for patients suffering from advanced gum disease.
How similar studies have performed: Preliminary results from similar approaches using photodynamic therapy have shown promising outcomes, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss. * ≥ 18 years old * Presence of ≥20 teeth, including implants * Agreement to participate in the study and to sign a written consent form * Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: * Grade A or C periodontitis * Presence of any physical limitation or restriction that might restrict Lumoral use * Pregnancy or lactation * Active smoking * Medicated diabetes mellitus (DM) * Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease * Use of antibiotics within 4 weeks week prior study * Periodontal treatment within 3 months prior study * Removable major prosthesis or major orthodontic appliance * A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Where this trial is running
Kaunas
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology — Kaunas, Lithuania (Recruiting)
Study contacts
- Principal investigator: Ingrida Marija Pacauskiene, Doctor — Lithuanian University of Health Sciences
- Study coordinator: Mikko Kylmänen, Bachelor
- Email: mikko.kylmanen@koitehealth.com
- Phone: +358407245934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.